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Hypersensitivity is an exaggerated response by the immune system to a drug or other substance.
FDA approves GSK's Tanzeum as once-weekly treatment for type 2 diabetes

FDA approves GSK's Tanzeum as once-weekly treatment for type 2 diabetes

GlaxoSmithKline plc today announced that the US Food and Drug Administration has approved Tanzeum (albiglutide) for injection, for subcutaneous use, as a once-weekly treatment for type 2 diabetes. Tanzeum has been approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. [More]
Access provides update on new formulation of anti-inflammatory drug amlexanox

Access provides update on new formulation of anti-inflammatory drug amlexanox

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP) provided an update on a new formulation of the anti-inflammatory drug amlexanox, called LexaGard™, for the treatment of inflammatory and ulcerative conditions of the esophagus. [More]
Pradaxa receives FDA approval for treatment and reduction of risk of recurrence of DVT and PE

Pradaxa receives FDA approval for treatment and reduction of risk of recurrence of DVT and PE

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Pradaxa® (dabigatran etexilate mesylate) for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated. DVT and PE are collectively referred to as venous thromboembolism (VTE). [More]

rEVO Biologics commences ATryn Phase 3 clinical program for treatment of preeclampsia in pregnant women

rEVO Biologics Inc., a subsidiary of LFB SA, today announced the initiation of the Phase 3 clinical program for ATryn for the treatment of preeclampsia in pregnant women during the 24th to 28th week of pregnancy. [More]
Halozyme meets primary endpoint in Hylenex CONSISTENT 1 trial

Halozyme meets primary endpoint in Hylenex CONSISTENT 1 trial

Halozyme Therapeutics, Inc. today announced that the primary endpoint of non-inferiority of A1C levels at six months was met for the CONSISTENT 1 trial. The trial is evaluating Hylenex® recombinant and a new formulation of Hylenex currently under U.S Food and Drug Administration (FDA) review, when used as pretreatment of the insulin infusion site in patients with type 1 diabetes receiving continuous subcutaneous insulin infusion (CSII) in comparison to no pre-treatment. [More]

Pierre Fabre Dermatologie receives FDA marketing authorization for pediatric drug Hemangeol

Pierre Fabre Dermatologie has obtained marketing authorization from the FDA for the pediatric drug Hemangeol (propranolol hydrochloride), which is the first and only approved treatment for "proliferating infantile hemangioma requiring systemic therapy". [More]
Merck's NOXAFIL injection gets FDA approval for intravenous use

Merck's NOXAFIL injection gets FDA approval for intravenous use

Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved NOXAFIL (posaconazole) injection (18 mg/ mL), a new formulation of NOXAFIL for intravenous (IV) use. [More]
Bristol-Myers Squibb, Pfizer announce FDA approval of Eliquis for DVT prophylaxis

Bristol-Myers Squibb, Pfizer announce FDA approval of Eliquis for DVT prophylaxis

Bristol-Myers Squibb Company and Pfizer Inc. today announced that the U.S. Food and Drug Administration approved a Supplemental New Drug Application (sNDA) for Eliquis (apixaban) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. [More]
AbbVie's PEARL-III study meets primary, secondary endpoints in patients with chronic GT1b HCV infection

AbbVie's PEARL-III study meets primary, secondary endpoints in patients with chronic GT1b HCV infection

The first detailed results from AbbVie's pivotal phase III study, PEARL-III, were presented today as part of the 21st Conference on Retroviruses and Opportunistic Infections (CROI) press conference and will also be presented as a late-breaker at the conference on March 4. [More]
Bayer Yakuhin submits marketing authorization application in Japan for EYLEA Injection

Bayer Yakuhin submits marketing authorization application in Japan for EYLEA Injection

Regeneron Pharmaceuticals, Inc. today announced that Bayer HealthCare's Japanese subsidiary, Bayer Yakuhin, Ltd., has submitted an application for marketing authorization for EYLEA (aflibercept) Injection for the treatment of patients with diabetic macular edema (DME) to the Japanese Ministry of Health, Labour and Welfare. [More]
Regeneron receives FDA acceptance for EYLEA injection for treatment of macular edema

Regeneron receives FDA acceptance for EYLEA injection for treatment of macular edema

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for standard review the Company's supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection for the treatment of Macular Edema following Branch Retinal Vein Occlusion (BRVO). [More]
FDA approves Iroko Pharmaceuticals’ TIVORBEX capsules

FDA approves Iroko Pharmaceuticals’ TIVORBEX capsules

Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, today announced that the U.S. Food and Drug Administration (FDA) has approved TIVORBEX™ (indomethacin) capsules, a nonsteroidal anti-inflammatory drug (NSAID), at 20 mg and 40 mg doses for the treatment of mild to moderate acute pain in adults. [More]
Onset Dermatologics launches 75mg strength of MINOCIN pellet-filled capsules to treat bacterial infections

Onset Dermatologics launches 75mg strength of MINOCIN pellet-filled capsules to treat bacterial infections

Onset Dermatologics, a leader in developing and commercializing prescription products for improving skin health, today announced the launch of a 75mg strength of MINOCIN (minocycline hydrochloride) Pellet-Filled Capsules. [More]

Researchers find new drug compound that treats laboratory mice with congenital heart disease

Congenital heart disease is the most common form of birth defect, affecting one out of every 125 babies, according to the National Institutes of Health. Researchers from the University of Missouri recently found success using a drug to treat laboratory mice with one form of congenital heart disease, hypertrophic cardiomyopathy - a weakening of the heart caused by abnormally thick muscle. [More]

Guerbet: FDA approves manufacturing plant for Lipiodol (ethiodized oil) Injection

Guerbet (GBT), the contrast agent specialist for medical imaging, today announced that it had received approval from the U.S. Food and Drug Administration (FDA) for a new manufacturing plant for Lipiodol® (ethiodized oil) Injection, in Montreal, Canada. [More]
Forest Laboratories plans to discontinue sale of NAMENDA 5 mg and 10 mg tablets

Forest Laboratories plans to discontinue sale of NAMENDA 5 mg and 10 mg tablets

Forest Laboratories, Inc., a leading, fully integrated, specialty pharmaceutical company largely focused on the United States market, today announced that it plans to discontinue the sale of NAMENDA (memantine HCl) 5 mg and 10 mg tablets effective August 15, 2014. [More]
Jazz Pharmaceuticals' Versacloz now commercially available in the U.S. for schizophrenia

Jazz Pharmaceuticals' Versacloz now commercially available in the U.S. for schizophrenia

Jazz Pharmaceuticals plc today announced U.S. commercial availability of Versacloz (clozapine, USP) oral suspension, the first and only oral suspension clozapine for severely ill treatment-resistant schizophrenia patients or those at risk of recurrent suicidal behavior with schizophrenia or schizoaffective disorder. [More]
Mallinckrodt's subsidiary to acquire all outstanding shares of Cadence Pharmaceuticals

Mallinckrodt's subsidiary to acquire all outstanding shares of Cadence Pharmaceuticals

Mallinckrodt plc, a leading global specialty pharmaceuticals company, and Cadence Pharmaceuticals, Inc. today announced that they have entered into a definitive agreement under which a subsidiary of Mallinckrodt plc will commence a tender offer to acquire all outstanding shares of Cadence Pharmaceuticals, Inc. for $14.00 per share in cash or approximately $1.3 billion on a fully diluted basis, which represents a 32% premium to the trailing 30-trading-day volume weighted average price (VWAP) of $10.62 per share for Cadence Pharmaceuticals, Inc. [More]

Mallinckrodt announces commercial launch of PENNSAID

Mallinckrodt today announced the commercial launch of PENNSAID (diclofenac sodium topical solution) 2% w/w (PENNSAID 2%). PENNSAID 2% is a topical non-steroidal anti-inflammatory drug (NSAID) approved for use in the treatment of the pain of osteoarthritis of the knees. [More]

University of Liverpool receives funding to continue reducing impact of adverse reactions to medicinal drugs

The Medical Research Council (MRC) Centre for Drug Safety Science at the University of Liverpool has received three million pounds of new funding from MRC to allow it to continue reducing the impact of adverse reactions to medicinal drugs. [More]